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FDA proposes unique device identification (UDI) system for medical devices

Alston & Bird LLP
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USA
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July 31 2012

On July 10, 2012, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (77 Fed. Reg. 40736) to establish a unique device identification (UDI) system for medical devices

FDA launches Reportable Food Registry

Alston & Bird LLP
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USA
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September 14 2009

On September 8, FDA issued Final Guidance for Industry providing questions and answers on compliance with the Reportable Food Registry requirements

Policy & hill update

Alston & Bird LLP
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USA
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September 14 2009

As Congress returns from the August recess, the mechanics of how the House and Senate will move forward with health care proposals are taking shape

FDAFSIS product tracing systems public meeting recap

Alston & Bird LLP
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USA
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December 16 2009

On December 9-10, FDA, in collaboration with the Food Safety and Inspection Service (FSIS), held a joint public meeting focused on gathering stakeholders to receive feedback on the key issues and challenges involving food product tracing systems

Positron Emission Tomography drugs current good manufacturing practice: final rule and guidance

Alston & Bird LLP
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USA
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December 16 2009

Last week, FDA announced final current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs

Use of patient-reported outcomes in drug and device labelingadvertising: final guidance

Alston & Bird LLP
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USA
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December 16 2009

Last week, FDA issued a guidance document for industry finalizing its 2006 draft guidance on the use of patient-reported outcome (PRO) measures and instruments (i.e., a patient questionnaire plus documentation to support its use) in product development and to support labeling claims

Food safety update

Alston & Bird LLP
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USA
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December 16 2009

With the considerable time that health care reform is taking in the U.S. Senate, it appears that food safety reform will not hit the floor of the Senate until early 2010

GAO finds FDA's postmarket safety efforts to be inadequate

Alston & Bird LLP
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USA
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December 16 2009

In a recent report, the U.S. Government Accountability Office (GAO) found that FDA's postmarket drug safety program remains deficient, although improved since GAO last looked at the program in 2006

Closing comment periods of note

Alston & Bird LLP
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USA
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December 16 2009

FDA is seeking comments on its proposed rule to codify current good manufacturing practice (cGMP) requirements for combination products

Electronic device registration & listing

Alston & Bird LLP
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USA
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April 16 2010

On March 26, 2010, the FDA published a proposed rule to require electronic registration and listing through its Unified Registration and Listing System (FURLS

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